Senior Regulatory Specialist
4 weeks ago
We're hiring Looking for an energetic Regulatory Affairs professionals join our team in Gurgaon.Job SummaryRegulatory submission of new products, variations, response to queries, Life cycle management for US and OAM region through preparation of quality dossiers enabling timely approvals.Area Of Responsibility1. New submissions:a. Review & prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions. b. Review documents (Development report, scale up report, specification, stability protocol, analytical validation), etc. Before initiation of Exhibit batches for adequacy.2. Approval : Review & prepare response to deficiency enabling approval of products filed to regulatory agency.3. Lifecycle management for drug formulations:a. Prepare and review variation , Annual notification and labelling approval for US and OAMb. Review of change control and file variation as per country requirement4. Regulatory compliance:a. eCTD compilationb. Ensure reposition of comprehensive product information into central repository C. Review regulatory filing impact of variations, change controls, etc.
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Senior Regulatory Specialist
1 week ago
Gurgaon, Haryana, India SUN PHARMA Full timeWe're hiring Looking for an energetic Regulatory Affairs professionals join our team in Gurgaon.Job SummaryRegulatory submission of new products, variations, response to queries, Life cycle management for US and OAM region through preparation of quality dossiers enabling timely approvals.Area Of ResponsibilityNew submissions:a. Review & prepare CMC...
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Senior regulatory specialist
4 weeks ago
Gurgaon, India SUN PHARMA Full timeWe're hiring!! Looking for an energetic Regulatory Affairs professionals join our team in Gurgaon.Job SummaryRegulatory submission of new products, variations, response to queries, Life cycle management for US and OAM region through preparation of quality dossiers enabling timely approvals.Area Of Responsibility1. New submissions:a. Review & prepare CMC...
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Associate- Drug Regulatory Affairs_US_
7 days ago
Gurgaon, Haryana, India DDReg Pharma Pvt. Ltd. Full timeJob PurposeWe are seeking a detail-oriented and proactive Regulatory Affairs Specialist to support global regulatory submissions and lifecycle management for pharmaceutical products. The ideal candidate will have hands-on experience with CTD/eCTD documentation, regulatory compliance, and dossier preparation, particularly for US Markets.Key...
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Associate- Drug Regulatory Affairs_Canada_
7 days ago
Gurgaon, Haryana, India DDReg Pharma Pvt. Ltd. Full timeJob PurposeWe are seeking a detail-oriented and proactive Regulatory Affairs Specialist to support global regulatory submissions and lifecycle management for pharmaceutical products. The ideal candidate will have hands-on experience with CTD/eCTD documentation, regulatory compliance, and dossier preparation, particularly for Canada Markets.Key...
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Regulatory Reporting Operations Specialist
7 days ago
Gurgaon, Haryana, India Innova AM Tech Full timeLocationGurgaon- DepartmentRegulatory Reporting / Client Services- Job Summary:- We are seeking a highly skilled and motivated Regulatory Reporting Solutions Specialist to manage and address regulatory inquiries, support daily reporting challenges, and aid in the resolution of technical issues across various global markets.- The ideal candidate will possess...
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Regulatory Reporting Senior Analyst
2 weeks ago
Gurgaon, Haryana, India Fidelity International Full time ₹ 6,00,000 - ₹ 18,00,000 per yearAbout the OpportunityJob Type: PermanentApplication Deadline: 08 November 2025Title Senior Analyst, Global Regulatory ReportingDepartment Global Regulatory ReportingLocation GurgaonReports To Global Regulatory Reporting Senior ManagerLevel Senior AnalystWe're proud to have been helping our clients build better financial futures for over 50 years. How have we...
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Regulatory Reporting Senior Analyst
1 week ago
Gurgaon, Haryana, India Fidelity International Full timeAbout the OpportunityJob Type: PermanentApplication Deadline: 08 November 2025 Title Senior Analyst, Global Regulatory ReportingDepartment Global Regulatory ReportingLocation GurgaonReports To Global Regulatory Reporting Senior ManagerLevel Senior Analyst We're proud to have been helping our clients build better financial futures...
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Specialist, Regulatory Affairs FDF
3 days ago
Gurgaon, Haryana, India Centrient Pharmaceuticals Netherlands Full timeSupporting the RA-FDF Team and contributing in the regulatory activities in order to achieve the objectives of the department which are: obtaining global approval for CENTRIENT products, including the lifecycle management of the registration dossiers according to business planning.Key Individual AccountabilitiesCollection of information and preparation of...
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Senior Regulatory Associate
7 days ago
Gurgaon, Haryana, India Syneos Health Full timeSenior Regulatory Associate (Expert- Veeva Vault,RIMS,Module 1)Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer...
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Gurgaon, Haryana, India DDReg Pharma Pvt. Ltd. Full timeJob PurposeThe Asst. Manager – Regulatory Affairs (GHC/KSA) will lead regulatory strategy, submissions, and compliance for pharmaceutical products intended for the ROW markets. This is an onsite role based in Gurgaon. The individual will serve as a key regulatory liaison, ensuring products meet all regulatory requirements, supporting lifecycle management,...